Abstract 11777: A Phase 3, Randomized, Partially Blinded, Active-Controlled, Study Assessing the Efficacy and Safety of Intramyocardial Autologous CD34+ Cell Administration in Patients with Refractory Angina: Design of the RENEW Study
Background: Preclinical data and early phase clinical trials suggest that intramyocardial administration of autologous CD34+ cells may improve functional capacity and symptoms of angina; however, definitive trials defining the efficacy of this therapy are needed. RENEW is a phase 3 trial designed to determine the efficacy of GCSF mobilized CD34+ stem cells for the treatment of patients with refractory angina.
Methods: Patients (n=444) lacking conventional revascularization options as determined by an independent prequalification committee with symptom limiting CCS class III and IV angina, ischemia on stress testing and anginal limitations to exercise during standardized exercise treadmill testing will be randomized 2:1:1 to cell therapy (G-CSF mediated stem cell mobilization, apheresis and intramyocardial injection of 1 x 105 Auto-CD34+ cells/kg), active control (G-CSF mediated stem cell mobilization, apheresis and intramyocardial placebo injection), or open label standard of care (SOC). The primary efficacy endpoint is change in exercise treadmill time in the treated vs. active control patients, with a secondary efficacy endpoint of total number of anginal episodes per week. The primary safety endpoint is the incidence of major adverse cardiac events (MACE) in treated vs. SOC patients. RENEW is powered to detect a 60 second difference in exercise time between cell treated (n=200) and active control (n=100) patients.
Conclusions: RENEW will be the first phase III study to define the efficacy of a cellular therapy (intramyocardial delivery of autologous-CD34+ cells) for a cardiovascular indication. The design and future results of RENEW will define the future development of regenerative cardiovascular therapies.
- Regenerative medicine stem cells
- Endothelial progenitor cell
- Clinical trials
- Interventional cardiology
- © 2012 by American Heart Association, Inc.